Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation
Effect of Low Frequency Pulsed Electromagnetic Field Therapy on Vibration Perception Threshold and Protective Sensation in Diabetic Foot Ulcer
Diabetes Mellitus (DM) is a chronic metabolic disorder characterized by hyperglycaemia for extended periods of time, which causes damage to peripheral nerves, resulting in sensory, motor and autonomic dysfunction. The study will aim to assess the effect of the Low pulse electromagnetic field therapy in VPT and protective sensation in the diabetic foot ulcer. The total number of participants will be 42 (calculated by epi tool) and the participants are to be divided among two groups. Non Probability Consecutive sampling technique will be used for this study.
The data collection tools will be Wagner Classification System for Diabetic Foot Ulcers, Numerical Pain Rating Scale, Goniometry, 10 g monofilament, Tuning Fork 128 Hz will be used. After meeting the inclusion and exclusion criteria and taking the written and verbal informed consent participants in one group will receive (low frequency pulsed electromagnatic field therapy and ankle Range of Motion) and other group will be receive (Sham PEMF and ankle Range of motion). Both interventions will be given three times weekly (or every other day) for 6 weeks. Vibrations perception, protective sensation, pain, ankle ROM and will be the outcome measures of the study. The data will be collected at baseline and 6 weeks. The data will be analyzed by using SPSS 23 and interpreted by using MS Word.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Dr. Rubina Zulfqar
- Número de telefone: +923414291664
- E-mail: drrubinazulfqar355@gmail.com
Locais de estudo
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Punjab Province
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Faisalabad, Punjab Province, Paquistão, 38000
- Recrutamento
- Dr Rubina Zulfqar
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Contato:
- Dr. Rubina Zulfqar
- Número de telefone: +923414291664
- E-mail: drrubinazulfqar355@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Participants must have a clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5) (Bolen et al., 2016).
- Patients with Wagner grade 1 diabetic foot ulcers was selected.
- Michigan Neuropathic Screening Instrument history score ≤7 (Viswanathan et al., 2025).
- Participants showing reduced vibration perception threshold on 128Hz Tunning fork was included to confirm the presence of sensory neuropathy Associated with diabetic ulcers (Viswanathan et al., 2025).
- Sensation on 10g monofilament less then 8 point out of 10 indicate reduces Sensation.
- Participants having diabetes for more than 10 years (Grewal et al., 2015).
- Pariticipants aged between 40 to 60 years.
- Both gender were included.
- Participants who was willing to give consent.
Exclusion Criteria:
- Participants who have significant cognitive impairment (e.g Dementia, Alzheimer) that would prevent them from understanding and adhering to Study instructions.
- Participants with active infections requiring systemic antibiotic therapy (Kwan et al., 2015).
- Patients with comorbidities such as malignancy, severe renal disease, or Other systemic condition.
- Participants who was not taking any medicine
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion
Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Table 2 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Experimental: Group B Ankle Range of Motion
Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Parameters Description Ankle Range of Motion Active ROM
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Vibration Perception Threshold
Prazo: 6 week
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Vibration perception threshold will be measured by using Tuning Fork 128 Hz. that check either the patient sense the vibration or not.
if person feel sensation grater than 10 second indicate decrease vibration perception.
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6 week
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Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).
Prazo: 6 weeks
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Protective sensation will be assessed using the 10-g monofilament at 10 standardized plantar sites.
One point is awarded for each site where the participant correctly perceives the monofilament, yielding a total score ranging from 0 to 10. Higher scores indicate better protective sensation.
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6 weeks
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Diabetic peripheral neuropathy
Prazo: 6 weeks
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Diabetic peripheral neuropathy will be measured by using Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment, the decrease in score showed improvement the total score consisting of 5 per foot overall 10, 0 indicate foot is healthy and 10 indicate worse condition.
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6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Range of Motion
Prazo: 6 weeks
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Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.
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6 weeks
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Pain intensity
Prazo: 6 weeks
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Pain intensity will be measured by using Numerical Pain Rating Scale, the scale consisting of 0 to 10 number 0 means no pain 10 mean worse pain the decrease in NPRS scores reflecting decreased pain intensity and increased comfort.
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6 weeks
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Colaboradores e Investigadores
Patrocinador
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Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TUF/EIRB/174/26
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